Gamification in Knee Replacement Rehabilitation

Knee Osteoarthritis Clinical Trial

— BEE-RCT  

Official title:

Effectiveness of Gamification in Knee Replacement Rehabilitation. Randomized Controlled Trial and Qualitative Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717727
• Other study ID #: T226/2018
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: January 17, 2022

Study information

• Verified date: July 2023
• Source: University of Jyvaskyla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After total knee arthroplasty (TKA), knee is usually swollen, painful, and stiff. The main goal of post-operative physical rehabilitation is to achieve full extension and flexion of the knee to avoid contractures and stiffness. Also strengthening of quadriceps muscle and balance to help activities of daily living and overall mobility are important. The post-operative knee replacement rehabilitation includes the standard protocol in hospital phase and the standard home exercise instructions. Computer based exercising games (exergames) may be new method to increase training adherence and volume after TKA and thus improve results and effectiveness of the rehabilitation. However, evidence of effectiveness of rehabilitative exergaming on physical functioning is sparse and more research is needed to conduct evidence-based rehabilitation practices. Therefore the present study examines the effectiveness of a 16-week gamified physiotherapy on physical functioning, life satisfaction and pain for patients after TKA compared to treatment as usual home exercise. The second objective is to validate the psychometric properties of WHODAS 2.0 (WHO Disability Assessment Schedule) and brief ICF (International classification of functioning, disability and health) core set of osteoarthritis questionnaire. Other objectives are to find out, what kind of understanding and experiences the participants have about the rehabilitation with exergames and to evaluate the usability and user experience of exergames.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 17, 2022
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• first primary (M17.0, M17.1) unilateral TKA
• mechanical axis of the limb in varus
• model of the TKA is posterior stabilizing (PS) or cruciate retaining (CR) prosthesis
• normal vision with or without eyeglasses

Exclusion Criteria:

• fractures, rheumatoid arthritis, or other biomechanical disruptions in affected lower limb within one year before operation
• diagnosed memory disorder or cognitive impairment
• neurological condition as Parkinson's disease, multiple sclerosis or stroke

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Exergame
16-week home-based exercise intervention with exergaming system and usual treatment.
• Control
16-week home-based exercise by standard protocol and usual treatment.

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä
Finland	University of Jyväskylä	Jyväskylä
Finland	Turku University Hospital	Turku
Finland	Turku University of Applied Sciences	Turku

Sponsors (5)

Lead Sponsor	Collaborator
University of Jyvaskyla	Jyväskylä Central Hospital, Turku University Hospital, Turku University of Applied Sciences, University of Oulu

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Aartolahti E, Janhunen M, Katajapuu N, Paloneva J, Pamilo K, Oksanen A, Keemu H, Karvonen M, Luimula M, Korpelainen R, Jamsa T, Makela K, Heinonen A. Effectiveness of Gamification in Knee Replacement Rehabilitation: Protocol for a Randomized Controlled Trial With a Qualitative Approach. JMIR Res Protoc. 2022 Nov 28;11(11):e38434. doi: 10.2196/38434. — View Citation

Janhunen M, Katajapuu N, Paloneva J, Pamilo K, Oksanen A, Keemu H, Karvonen M, Luimula M, Korpelainen R, Jamsa T, Kautiainen H, Makela K, Heinonen A, Aartolahti E. Effects of a home-based, exergaming intervention on physical function and pain after total — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	Physical activity diary	Through study completion, an average of 1 year
Other	Satisfaction with the operated knee	Questionnaire	2, 4 and 12 months post-operative
Primary	Change in Function and pain related to knee	Oxford Knee Score	Change from pre-operative baseline at 2 and 4 months post-operative.
Primary	Change in Mobility	Timed Up and Go	Change from pre-operative baseline at 2 and 4 months post-operative.
Secondary	Change in Function and pain related to knee	Oxford knee score	Change from pre-operative baseline at 12 months post-operative.
Secondary	Change in Mobility	Timed Up and Go	Change from pre-operative baseline at 12 months post-operative.
Secondary	Change in Walking	10-m Walking speed	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in Lower extremity performance	Short Physical Performance Battery	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in Muscle strength	Isometric knee extension and flexion strength	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in Knee range of motion	Goniometer	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in knee pain (VAS)	Visual analogue scale (0 to 100 mm), Constant score (0 to 100 points)	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in Disability	WHO disability scale (WHODAS 2.0.)	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in Pain	Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on pain.	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in other symptoms such as swelling, restricted range of motion and mechanical symptoms	Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on symptoms	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in quality of life (QOL)	Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on QOL	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in activities of daily living (ADL) Function	Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on ADL	pre-operative baseline and 2, 4 and 12 months post-operative
Secondary	Change in Sport and Recreation Function	Knee injury and Osteoarthritis Outcome Score (KOOS) subscale on Sport and Recreation Function	pre-operative baseline and 2, 4 and 12 months post-operative

External Links

•   Primary results
•   Study protocol